GLUCOSE (UV HEXOKIASE) REAGENT SET

GLUCOSE (UV HEXOKIASE) REAGENT SET is an FDA 510(k)-cleared medical device (K855153) manufactured by Technostics Intl.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 1986. Regulation: 8.